EpiPen Controversy Fuels Concerns Over Generic Drug Approval Backlog

FDA has collected $1 billion from generic drug manufacturers but has only moved through half of the drugs backlogged for approval since 2012. (Heidi de Marco/KHN)

Consumers and Congress members pushing for cheaper alternatives to the EpiPen and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration that still stretches almost four years.

As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, or GPhA. The FDA has approved more generics the past few years, but a flood of new applications has steadily added to the demand.

By comparison, the European Medicines Agency, Europe’s version of the FDA, has just 24 generics or biologically-based “biosimilars” awaiting approval. (The FDA’s count does not include biosimilars.) And the EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand name drugs in about a year on average, according to the EMA.

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long.

“We are concerned that Mylan (maker of the EpiPen) has not faced much competition for its product,” five U.S. senators wrote in August to FDA Commissioner Dr. Robert Califf, adding that one of EpiPen’s non-generic competitors, Auvi-Q was recalled in October, granting Mylan a near monopoly. “News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved.”

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Last week, three members of the House Committee on Energy and Commerce wrote a similar letter to the FDA, seeking information about the EpiPen generic applications it has received and how they’ve been prioritized.

When asked whether the FDA holds any responsibility for the lack of EpiPen competition, FDA spokesman Kristofer Baumgartner said he couldn’t comment on pending applications or confirm their existence, citing confidentiality rules. But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved a record number of generics in 2015.

“The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement,” Baumgartner said.

In March, Teva Pharmaceuticals told investors that its generic version of EpiPen — the life-saving allergy treatment – was rejected by the FDA, and that it wouldn’t be able to launch the generic until at least 2017. Adamis Pharmaceuticals reported a similar rejection from the FDA for its EpiPen generic in June.

Mylan has said it will offer a $300 generic in the coming weeks. Because Mylan also makes the brand name product, it will not have to wait in line behind other pending generics. And Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said this may deter other generic manufacturers from seeking approval.

Adrenaclick is the only other epinephrine auto-injector on the market, but it is not a generic for EpiPen and cannot be swapped out at the pharmacy if a doctor has written a prescription for EpiPen. It’s also not widely available, Baker said.

“You call up 100 pharmacies, and maybe 10 have the device, from what we gather,” Baker said of Adrenaclick, adding that several factors have allowed EpiPen’s price tag to swell over the years. “Is Mylan doing anything illegal? No. It’s taking advantage of all these things to take the market and basically push it to an extreme.”

Efforts To Speed The Approval Process

The FDA’s generic backlog isn’t a new problem. In 2012, it was so large that it prompted the government to start charging user fees to generic manufacturers to provide the funds for the FDA to speed the process. The fees built on the 20-year-old Prescription Drug User Fee Act, which required brand name drug manufacturers to pay fees to increase FDA efficiency. In the first three years, the FDA collected $1 billion from generic drug manufacturers.

The fees were used to hire an additional 1,000 employees, and put the Office of Generic Drugs on par with the Office of New Drugs by re-organizing it, and moving it to the FDA’s main campus from four buildings in Rockville, Maryland. The funds were also used to replace the office’s information technology system and implement a few other changes.

As the FDA notes on its website, “Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.”

In October 2012, there was a backlog of 2,868 generic drugs awaiting approval, and the FDA said it would take a “first action” on 90 percent of these drugs by 2017. This summer, the agency met its goal a year early, but a first action isn’t an approval. Only 1,551 generics have been approved since the fees were initiated, and that includes some extras that weren’t considered part of the official backlog. So the agency has only approved about half of the backlogged generics that were awaiting approval in 2012.

“Most applications from the backlog will need to come back to FDA for additional review due to deficiencies in the submissions, before approval is possible,” the agency said in a statement in responses to questions.

The GPhA argues that the agency has declared applications to be “of ‘poor quality’ because they don’t meet new, more recent standards updated while these applications sit in the backlog.”

The applications for generic drugs have continued to pile up even as the FDA approved a record number of generics in 2015 and again in the first seven months of 2016. The number of generic drug applications tripled from 2002 to 2012, according to January congressional testimony from Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research.

Still, some observers are hopeful.

“I think that it is an optimistic picture overall … at the FDA, there’s been a lot of progress, and I think there is more to be made,” said Dr. Aaron Kesselheim, who leads a research program at Harvard Medical School and Brigham and Women’s Hospital. “This is not something that people should think has been solved at this point. It’s totally an ongoing process.”

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